ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2594

Trajectories of Forced Vital Capacity (FVC) in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Oliver Distler1, Madelon Vonk2, Arata Azuma3, Maureen Mayes4, Dinesh Khanna5, Kristin B Highland6, Gerrit Toenges7, Margarida Alves8 and Yannick Allanore9, 1Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, 2Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, 3Pulmonary Medicine and Oncology, Nippon Medical School, Tokyo, Japan, and Meisei Hospital, Saitama, Japan, 4Division of Rheumatology, University of Texas McGovern Medical School, Houston, TX, 5University of Michigan, Ann Arbor, MI, 6Cleveland Clinic, Cleveland, OH, 7Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany, 8Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 9Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France

Meeting: ACR Convergence 2023

Keywords: , ,

Session Information

Date: Wednesday, November 15, 2023

Title: Abstracts: Systemic Sclerosis & Related Disorders III: Clinical Trials

Session Type: Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: The SENSCIS trial enrolled patients with SSc-ILD without a requirement for them to have evidence of recent progression. During the trial, nintedanib reduced the rate of decline in FVC (mL/year) versus placebo. The open-label extension of the SENSCIS trial, SENSCIS-ON, assessed changes in FVC in patients treated with nintedanib over the longer term. We assessed the trajectory of FVC decline in patients who received placebo in the SENSCIS trial and then nintedanib in SENSCIS-ON.

Methods: In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo double-blind until the last patient reached week 52 but for ≤100 weeks. Patients who completed the SENSCIS trial on treatment (nintedanib or placebo) and attended a follow-up visit were eligible to enter SENSCIS-ON. The protocol allowed an off-treatment period between SENSCIS and SENSCIS-ON of ≤12 weeks. We calculated the trajectory of FVC in patients who received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON. The baseline measurement in SENSCIS-ON was considered the anchor measurement (time point 0) (Figure 1). FVC was measured at time points before the anchor measurement (when patients were receiving placebo in SENSCIS or were off treatment between SENSCIS and SENSCIS-ON) and at time points after the anchor measurement (when patients were receiving open-label nintedanib in SENSCIS-ON). Analyses were descriptive and based on observed FVC values.

Results: In total, 231 patients received placebo in SENSCIS and then nintedanib in SENSCIS-ON. In these patients, mean (SD) FVC was 2593 (833) mL at baseline of SENSCIS and 2441 (833) mL at baseline of SENSCIS-ON. The mean decline in FVC in the 52 weeks prior to baseline of SENSCIS-ON (when patients were receiving placebo in SENSCIS or were off treatment) was −98.5 mL (Figure 2). The mean decline in FVC from baseline of SENSCIS-ON to week 52 of SENSCIS-ON (when patients were receiving nintedanib) was −42.8 mL (Figure 2).

Conclusion: In patients who received placebo in the SENSCIS trial, the decline in FVC over 52 weeks was reduced by approximately 57% following initiation of open-label nintedanib in SENSCIS-ON. These analyses illustrate the progressive nature of SSc-ILD in the population enrolled in SENSCIS and the effectiveness of nintedanib on slowing the progression of SSc-ILD.

Supporting image 1

Figure 1. Method for pooling FVC data in SENSCIS and SENSCIS-ON

Supporting image 2

Figure 2. Trajectory of FVC in patients who received placebo in the SENSCIS trial followed by nintedanib in SENSCIS-ON

Disclosures: O. Distler: 4P-Pharma, 2, 5, 6, AbbVie, 2, 5, 6, Acceleron, 2, 5, 6, Alcimed, 2, 5, 6, Altavant Sciences, 2, 5, 6, Amgen, 2, 5, 6, AnaMar, 2, 5, 6, Arxx, 2, 5, 6, AstraZeneca, 2, 5, 6, Bayer, 2, 5, 6, Blade Therapeutics, 2, 5, 6, Boehringer Ingelheim, 2, 5, 6, Citus AG, 12, Co-Founder, Corbus Pharmaceuticals, 2, 5, 6, CSL Behring, 2, 5, 6, Galapagos, 2, 5, 6, Galderma, 2, 5, 6, Glenmark, 2, 5, 6, Gossamer, 2, 5, 6, Horizon Therapeutics, 2, 5, 6, Janssen, 2, 5, 6, Kymera, 2, 5, 6, Lupin, 2, 5, 6, Medscape, 2, 5, 6, Miltenyi Biotec, 2, 5, 6, Mitsubishi Tanabe, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143), 10, Prometheus Biosciences, 2, 5, 6, Redx Pharma, 2, 5, 6, Roivant, 2, 5, 6, Topadur, 2, 5, 6; M. Vonk: Boehringer Ingelheim, 5, 6, Corbus, 1, EUSTAR, 4, Ferrer, 5, Galapagos, 5, Janssen, 5, 6, MSD, 6, Systemic Sclerosis ERN ReCONNET, 4; A. Azuma: Boehringer Ingelheim, 2, 5, 6, Kyorin Pharma, 2, Taiho, 2, Toray, 2; M. Mayes: Boehringer Ingelheim, 1, 5, British Medical Journal, 9, Corbus, 5, EICOS, 1, 5, Horizon Pharma, 5, Medtelligence, 6, Mitsubishi Tanabe, 1, 5, Oxford University Press, 9, Prometheus, 5, Springer International Publishing, 9; D. Khanna: AbbVie, 12, DSMB, AstraZeneca, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb, 2, 5, CSL Behring, 2, Genentech, 2, Horizon Therapeutics, 2, 5, Janssen, 2, 6, Pfizer, 5, Prometheus, 2; K. Highland: Boehringer Ingelheim, 2, 5, 6, Scleroderma Foundation, 1; G. Toenges: Boehringer Ingelheim, 3; M. Alves: Boehringer Ingelheim, 3; Y. Allanore: AbbVie, 6, AstraZeneca, 1, Boehringer Ingelheim, 1, 2, 6, Chemomab, 1, Curzion, 1, Janssen, 6, Medsenic, 1, Menarini, 1, Prometheus, 1, Sanofi, 1, 2.

To cite this abstract in AMA style:

Distler O, Vonk M, Azuma A, Mayes M, Khanna D, Highland K, Toenges G, Alves M, Allanore Y. Trajectories of Forced Vital Capacity (FVC) in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/trajectories-of-forced-vital-capacity-fvc-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild/. Accessed .

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